Registered with: The Division of Assurance and Quality Improvement Office for Human Research Protections (OHRP) U.S. Department of Health and Human Services

CMS-IRB (a registered body since 2007), is an institutional review board, having representation of professionals from CMS, other like-minded organizations and independent consultants. Till date it has reviewed around 100 research and evaluation protocols from ethics lens. List of CMS-IRB Reviewed Protocols.

What is Research Ethics Committee (or IRB)? Committee which has the power & ability to give an opinion about the ethical aspects of a research protocol involving human subjects Primary responsibility is to ensure that all research respects the dignity, rights and safety, as well as the well-being of all research participants. To facilitate the good conduct of high quality research that offers benefits to participants, services and society as a whole.

Why do we need an ethical review?Relevance of practicing ethical norms is increasing day by day in the field of social research and evaluation, particularly in India, with around 1.3 billion population living in a religiously, culturally diverse multi-lingual society. Yet, in India, institutionalized review of ethical practices in non-clinical research/evaluation is scarce, almost non-existent.

What needs to be reviewed by the IRB? Any research involving human subjects  Study design [protocol, subject, sampling, and plan of dissemination] Consent forms in local languages  Research tools with translation Principal Investigator’s (PI) statement of adhering with proposed design and translation  Perceived risk as stated by PI and proposed actions to minimize those risks

What happens post review? Post review, comments and inputs given by the review board are shared with PI of the study.  After incorporating the comments/inputs, final version of the research protocol is submitted to CMS-IRB.  After reviewing the revised research, an Approval Certificate signed by Chairperson/Vice-Chairperson, CMS-IRB is shared with PI. PI has to duly sign the Approval Certificate and a scanned/hard copy of the same is submitted to CMS-IRB for records purposes. This completes the review process. Any amendment in the research protocols, post issuance of Approval Certificate, has to be mandatorily informed to CMS IRB for approval, else the Approval Certificate stands null & void.